MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY

Model Number	22015875
Medical Device Problem Codes	Product Quality Problem (1506); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Date of incident: (b)(6) 2024 it was reported that a small power dome broke away from wire and ended up in members ear on (b)(6) 2024.Providers sent member to physician for removal as piece was sideways and they had no options for removal.The object was removed from ear by physician and there is no damage to the ear canal.No further information is expected.There was no harm to the user as a result of this incident.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.Clinical conclusion: clinical evaluation of the event: it was reported that a small power dome broke away from wire and ended up in members ear on (b)(6) 2024.Providers sent member to physician for removal as piece was sideways and they had no options for removal.The object was removed from ear by physician and there is no damage to the ear canal.No prior issues of this kind for the user.The clinical evaluation is that there was no harm to the user as a result of this event.The clinical evaluation for the device family does evaluate receivers coming loose in the ear canal.This is identified in the risk analysis and mitigated through device design by ensuring a sufficient pull force (compliance with iec 60601-2-66).The user guide states to contact the hcp if a foreign object or wax is located in the ear canal to reduce the potential risk of harm as far as possible.There are no new clinical aspects (e.G.Unforeseen use or clinical conditions) discovered from this event.Therefore, it is concluded that the current clinical evaluation and risk/benefit conclusions herein are sufficient.Check this!!!!! risk assessment: known risk.Considered in the risk analysis and deemed to be of an acceptable nature.Manufacturer's investigation is final.This is a combined (initial and final) report.

• Brand Name: GN RESOUND
• Common Device Name: HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• Manufacturer Contact: akanksha roy ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 19040691
• Report Number: 3005650109-2024-00036
• Device Sequence Number: 8482975
• Product Code: OSM
• UDI-Device Identifier: 05708296221974
• UDI-Public: 05708296221974
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 22015875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male